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    DRUG:

    HLX22

    i
    Other names: HLX22, AC-101, AC101, HLX-22, HLX 22
    Company:
    AbClon, Alligator Biosci, Fosun Pharma
    Drug class:
    HER2 antagonist
    Related drugs:
    1m
    A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma (ChiCTR2500109825)
    P2, N=45, Not yet recruiting, ZHONGSHAN HOSPITAL; ZHONGSHAN HOSPITAL
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • gemcitabine • albumin-bound paclitaxel • HLX22
    6ms
    A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov)
    P2, N=50, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • HLX22
    10ms
    A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • HLX22
    11ms
    HLX22-GC-301: A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer (clinicaltrials.gov)
    P3, N=550, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    over1year
    A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer (clinicaltrials.gov)
    P3, N=550, Not yet recruiting, Shanghai Henlius Biotech
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    over1year
    A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. (PubMed, Med)
    Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.
    Clinical • P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    capecitabine • oxaliplatin • Hercessi (trastuzumab-strf) • HLX22
    over1year
    Dual targeting non-overlapping epitopes in HER2 domain IV substantially enhanced HER2/HER2 homodimers and HER2/EGFR heterodimers internalization leading to potent antitumor activity in HER2-positive human gastric cancer. (PubMed, J Transl Med)
    These results suggested that the application of non-competing antibodies HLX22 and HLX02 targeting HER2 subdomain IV together may be of substantial benefit to gastric cancer patients who currently respond suboptimal to trastuzumab therapy.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor) • mTOR (Mechanistic target of rapamycin kinase) • STAT3 (Signal Transducer And Activator Of Transcription 3) • TGFB1 (Transforming Growth Factor Beta 1) • PI3K (Phosphoinositide 3-kinases)
    |
    Hercessi (trastuzumab-strf) • HLX22 • Poherdy (pertuzumab-dpzb)
    over1year
    Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Apr 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    almost2years
    HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study. (ASCO-GI 2024)
    Adding HLX22 to HLX02 + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. Clinical trial information: NCT04908813. >*Hazard ratio (HR) was estimated between group A and C, as well as between group B and C. NE, not evaluable; NR, not reached.
    Clinical • P2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    capecitabine • oxaliplatin • Hercessi (trastuzumab-strf) • HLX22
    over2years
    HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. (PubMed, Invest New Drugs)
    HLX22 was well tolerated in patients with advanced solid tumors overexpressing HER2 after failure of standard therapies. The study results support further investigation of HLX22 in combination with trastuzumab and chemotherapy.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • HLX22
    over3years
    Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2 (clinicaltrials.gov)
    P1, N=11, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed
    Trial completion
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 mutation
    |
    HLX22
    over3years
    Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22